Cleared Traditional

K013554 - POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

K013554 is an FDA 510(k) clearance for POLYMER COATED POWDER FREE LATEX MEDICA..., manufactured by Maxter Glove Manufacturing Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K013554 · Maxter Glove Manufacturing Sdn Bhd · General Hospital
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Jan 2002
Decision
84d
Days
Class 1
Risk

K013554 is an FDA 510(k) clearance for the POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABE.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Maxter Glove Manufacturing Sdn Bhd (Klang Selangor, MY). The FDA issued a Cleared decision on January 17, 2002 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maxter Glove Manufacturing Sdn Bhd devices

FDA 510(k) Submission Details - K013554

510(k) Number K013554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2001
Decision Date January 17, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYY Latex Patient Examination Glove

All 912
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K013554.
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K013794 · Shen Wei (Usa), Inc. · Jan 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
K013795 · Shen Wei (Usa), Inc. · Jan 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013498 · Maxter Glove Manufacturing Sdn Bhd · Jan 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013589 · Supermax Glove Manufacturing Sdn Bhd · Jan 2002
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
K013942 · Wrp Specialty Products Sdn. Bhd. · Dec 2001
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
K013320 · Arista Latindo Industrial Ltd. P.T · Dec 2001